Mesenchymal stromal cells-derived extracellular vesicles (MSC-EVs) are in line to become key players in future generation therapies. With numerous successful applications already reported, MSC-EVs clinical implementation still faces some headwinds related to biomanufacturing challenges, and particularly the capacity to fulfill clinical demand.
In a recent study published in the Journal of Extracellular Biology, iBB researchers (Ricardo M. Silva, Sara Sousa Rosa, José A. L. Santos, Ana M. Azevedo and Ana Fernandes-Platzgummer) have combined the advances achieved in our research group, together with literature observations to construct a simulation platform focused on the large-scale biomanufacturing of MSC-EVs. Using a detailed description, the simulation tool facilitates process monitoring, enabling the identifications of key components at each stage of the manufacturing – from MSC thawing to final doses formulation. In addition, in this study the authors do not neglect key operational aspects indispensable to the biomanufacturing of clinical-grade goods, such as facility, labour, consumables and utilities, which inevitable increase final impact cost of goods (COG) and final therapy price. Indispensable to the process, MSC, and their respective therapeutic value is also considered, contributing to the COG reduction. Ultimately, the authors present for the first time what could be the cost of MSC-EVs therapies implementation but also offer valuable insights regarding the optimization of MSC and MSC-EVs production methods, that at the end help the advance of regenerative medicine field, bringing these therapies closer to patients.
Link to publication: https://doi.org/10.1002/jex2.70037
The study was developed under the scope of the projects: UIDB/04565/2020 and UIDP/04565/2020 of the Research Unit Institute for Bioengineering and Biosciences-iBB; LA/P/0140/2020 of the Associate Laboratory Institute for Health and Bioeconomy-i4HB, and PTDC/EQU-EQU/31651/2017 of EXOpro.